How important is pet food safety to the average American? The American Pet Products Association has estimated that 70% of U.S. households own a pet, including more than 100 million households with at least one dog or cat. In recent years, consumer demand for premium and specialty pet food products has fueled a spike in U.S. sales of pet food to nearly $30 billion annually. Due to the growing consumer demands for high-quality pet food and an increasingly complex pet food supply chain, it seems the safety of animal food has never been more important.

To date this year, more than 50 pet food products have been recalled in the U.S. due to food safety issues, including microbial hazards such as Salmonella spp. In recent years, microbial hazards in pet food have become a North American public health issue and the economic adulteration of pet foods has resulted in hundreds of pet food recalls and animal deaths.

Addressing the upward trend in pet food safety issues, the U.S. Food and Drug Administration (FDA) unveiled the final version of its rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” in 2015. As mandated by the Food Safety Modernization Act (FSMA), the final rule established a new food safety focus applicable to the majority of facilities involved in the manufacturing, processing, packing and holding of animal food. The FDA recently announced plans to launch animal food facility inspections this year to verify compliance with the rule.

Expect Greater Oversight of Pet Food Facilities

For the first time, regulatory compliance dates for the animal food preventive controls are now in effect for all three business sizes (large, small and very small). Effective September 2018, all large animal food businesses should be prepared for routine federal inspections that will scrutinize both Current Good Manufacturing Practices (CGMPs) and preventive controls. Large animal food facilities were required to comply with the preventive controls rule by September 18, 2017, but inspections were delayed as part of the FDA “educate before and while we regulate” approach.

Beginning this year, the FDA has shifted its focus for small and very small businesses to increase the oversight of CGMPs through more routine facility inspections. Small businesses were expected to comply with the new requirements for CGMPs by September 2017. All small animal food businesses were advised to comply with the preventive controls requirements by September 17, 2018. However, the FDA has indicated that routine inspections of small facilities for preventive controls will not occur until 2019 unless a food safety problem triggers a “for cause” inspection of the facility.

During an FDA inspection, large animal food facilities must demonstrate compliance with the hazard analysis and risk-based preventive controls requirements, including the implementation of a food safety plan. Animal food facilities are required to evaluate their operations for hazards (biological, chemical, physical and radiological). Based on the hazard analysis, the food safety plan would address preventive controls (if applicable), monitoring procedures, corrective actions, verification activities, and a recall plan if hazards are reasonably likely to occur.  

In January 2018, the FDA issued a draft guidance entitled, “Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” which provides support regarding the food safety plan requirements, recommendations for conducting a hazard analysis, hazards associated with animal food, examples of preventive controls and preventive control management components.

Is a Supply Chain Program Mandatory?

Ensuring the safety of the supply chain is a critical element of the FSMA regulations for Foreign Supplier Verification Programs (FSVP) for Importers as well as the rules for preventive controls.  

The animal food preventive controls rule requires manufacturers to develop and implement a risk-based supply chain program if its hazard analysis determines a hazard would require a preventive control and the control would be applied in the facility’s supply chain. A supply chain program is not required in cases when the hazard is controlled within the manufacturer’s facility or controlled by their customer.

If a manufacturer determines that raw materials and other ingredients require a control within their supply chain, then the facility should source such materials from approved suppliers. The regulations permit the use of unapproved suppliers on a temporary basis only if the “raw materials are subject to verification activities before being accepted for use.”

In June 2018, the FDA issued a draft guidance to advise animal food facilities regarding the application of a supply chain program in compliance with the preventive controls rule. The guidance addresses the need for a supply-chain program, and advises facilities regarding the identification and implementation of appropriate supply-chain program activities. Moreover, it provides additional recommendations regarding verification activities, record keeping requirements and applicability of the FSVP rule to animal food importers.

The guidance suggests appropriate supplier verification activities like:

  • Onsite audits
  • Sampling and testing of raw material(s) or other ingredient(s)
  • Review of the supplier’s relevant food safety records, or
  • Other appropriate supplier verification activities based on supplier performance and the risk associated with the raw material or other ingredient

According to the draft guidance, animal food facilities should consider three factors when approving suppliers and determining the appropriate supplier verification activities and frequency. Animal food facilities should consider: (1) the hazard analysis of the animal food; (2) the entity or entities that will apply controls for the hazards requiring a supply chain control; and (3) the supplier’s performance related to food safety.

Tools for Managing Your Pet Food Supply Chain

Ensuring the safety of pet food is an evolving regulatory priority. In order to comply with the new FSMA mandates for preventive controls and supplier verification, the animal food industry should capitalize on the value of monitoring their supply chain data.

Supplier audits are one of the most effective tools for ensuring the quality and safety of your ingredients, additives, packaging or services provided by contractors. Accredited auditors can examine your supplier’s organization, food safety management system and the sanitary conditions of their premises, equipment and facilities.

For importers, supplier verification activities could require the onsite auditing of foreign suppliers, sampling and testing of imported food and the review of foreign supplier safety records.  

The role of environmental monitoring as a verification measure for preventive controls should not be underestimated. Due to the known biological hazards associated with pet food and animal feed, an environmental monitoring program can verify the effectiveness of sanitation controls designed to control microbial pathogens.

Are you looking for a way to make tracking and analyzing your environmental monitoring data easier? Consider implementing EnviroMap®, Mérieux NutriSciences’ cloud-based environmental monitoring solution, allows food companies to easily schedule, map and track their sampling procedures. Additionally, customizable dashboards give manufacturers the ability to view and analyze their data over time to recognize trends.

Merieux NutriSciences is now offering a professional information research services for a deep search and review of scientific literature and regulatory information.

 

 

Patrick Kennedy

Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

The potential risk of unsafe chemicals in foods has generated significant attention on social media in recent years due to growing consumer demands for “clean food” and food safety. Within the United States, the infamous Proposition 65 law in California is responsible for the majority of warning labeling requirements for chemical contaminants, but there has been an upward trend in state legislative proposals related to the risk of certain chemicals in consumer products. In response to this trend, several major food industry associations have joined forces to support a new federal bill titled the Accurate Labels Act, which seeks to impose more stringent scientific criteria for warning labels related to chemicals. If the bill becomes law, it could supersede or undermine the various state labeling requirements for chemical contaminants if the state rules are not grounded in the “best available science.” Continue Reading

The expression “may you live in interesting times” can be both a blessing and a curse. In North America, we are certainly living in interesting, challenging times for the food industry. The trade tariff wars and the uncertain fate of the North American Free Trade Agreement (NAFTA) may leave companies operating within the United States, Canada and Mexico with a sense of instability. However, despite the political challenges, food safety regulations within North America are evolving in positive ways.

As the U.S. continues the implementation of the Food Safety Modernization Act (FSMA), Canada recently unveiled new regulations to implement its Safe Food for Canadians Act (SFCA). Will the new Canadian rules align with the U.S. FSMA regulations to harmonize food safety requirements and streamline trade between the countries? Let’s take a closer look at the most recent developments below. Continue Reading

Supplier verification, as mandated by the Food Safety Modernization Act (FSMA), evokes sentiments such as the Russian proverb “trust but verify” or the expression “don’t buy a pig in a poke.” Food manufacturers are now required to monitor the origins of their ingredients closer than ever before. The FSMA food supply chain program requirements expect food facilities and importers to understand the food compliance history of their suppliers. But should firms also be expected to verify the controls of their suppliers’ ingredient suppliers? Continue Reading

Food industry associations and consumer advocacy groups have influenced the development of many key U.S. food policies and regulations, but the impact of consumer lawsuits upon the regulatory process cannot be denied. Since 2008, the number of class action lawsuits filed against food and beverage companies has increased from approximately twenty to more than a hundred lawsuits annually in recent years. While some of the legal challenges could be dismissed as frivolous, several cases have fueled the evolution of significant labeling and safety regulatory initiatives that are now under consideration by the U.S. Food and Drug Administration (FDA).    Continue Reading

Would mandatory front-of-pack nutrition labels or a symbol to designate a food as ‘Healthy,’ help curb the incidence of diet-related chronic diseases? Academic and industry research has shown that nutrition information on the front of food packages is more commonly viewed by American adult consumers than the Nutrition Facts panel, which is placed on the side or back of a package. The increased viewing of nutrition information is associated with healthier dietary patterns. While several countries are advancing regulations for front-of-pack (FOP) nutrition labeling schemes, the future of a mandatory FOP system in the U.S. remains uncertain. Continue Reading

Questions about the safety of fresh produce are in the headlines again following recent North American outbreaks involving Salmonella in sprouts, Salmonella in papayas and E. coli O157:H7 linked to romaine lettuce. Moreover, the Produce Safety rule of the Food Safety Modernization Act (FSMA) took effect for large farms in January, and the U.S. Food and Drug Administration (FDA) implemented the next stage of its targeted sampling program for fresh produce and related commodities. Continue Reading

A recall is a potential source of anxiety for any food manufacturer, but, if conducted effectively, recalls can be an invaluable tool for protecting a company’s reputation, brand image and sales. However, a recent government study has identified deficiencies in the food recall processes of the Food and Drug Administration (FDA), which has prompted the agency to propose new policies for improving the oversight, communication and implementation of its recall process.   Continue Reading